NCT04465500进行中（未招募）2 期
Prospective Trial of Combination External Beam Radiation Therapy and MRI-guided, Dose-differentiated High Dose-rate Prostate Brachytherapy Boost for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Compare GU toxicity rate to the rate published in the ASCENDE-RT trial
研究概览
简要总结
This study is trying to find out if the combination of Androgen deprivation therapy (ADT), MRI guided high dose radiation (HDR) brachytherapy treatment (internal radiation implant procedure) and external beam radiation therapy (EBRT) treatments lead to less side effects. This study is also looking at patient outcomes, quality of life, and overall survival for patients receiving this treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male, aged 18 or above.
- •Histologic proven diagnosis of cancer of the prostate up to one year before registration.
- •Unfavorable-intermediate risk, high risk, or very high-risk prostate cancer as determined by the NCCN Guidelines Version 4.2019 (Section 12.4).
- •History and physical exam completed up to 6 months before registration.
- •PSA value < 50 ng/mL prior to androgen deprivation therapy and up to 12 months before registration. Subjects who do not meet this criteria's timeframe due to extenuating circumstances (i.e. COVID-19 quarantine, changes to their treatment plan, etc) but meet all other eligibility criteria may still be eligible. The PI will review each case and decide
- •ECOG performance status 0 or
- •Pelvic MRI obtained up to 12 months before registration.
- •Candidate for receiving the combination of HDR brachytherapy and EBRT, with or without ADT. The ADT may have begun prior to study enrollment.
排除标准
- •Evidence of bone metastases.
- •Diagnosis of a prior invasive malignancy (except for non-melanoma skin cancer), unless the participant has been disease-free for at least 3 years.
- •Patient has had previous radical surgery (prostatectomy) or cryosurgery for prostate cancer.
- •Patient has had previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy.
- •Patient has had prior radiotherapy, including brachytherapy, to the region of this study cancer that would result in overlap of radiation therapy fields.
- •Patient has had previous or concurrent cytotoxic chemotherapy for prostate cancer (prior chemotherapy for different cancer is allowed).
- •Patient has MRI incompatible metallic implant(s) that cannot be removed.
- •The patient has severe or active co-morbidities as defined by the following:
- •Unstable angina and/or congestive heart failure requiring hospitalization up to 6 months (180 days) before registration
- •Transmural myocardial infarction up to 6 months (180 days) before registration
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulation effects or severe liver dysfunction.
- •Acquired immune deficiency syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be slightly immunosuppressive. Protocol- specific requirements may also exclude immuno-compromised patients.
研究组 & 干预措施
Treatment
Other
干预措施: External Beam Radiation (Radiation)
Treatment
Other
干预措施: HDR Brachytherapy (Radiation)
Treatment
Other
干预措施: Androgen Deprivation Therapy (Drug)
结局指标
主要结局
Compare GU toxicity rate to the rate published in the ASCENDE-RT trial
时间窗: 2 years
Grade 3 GU toxicity rate as measured by CTCAE v5.0
次要结局
- Estimate rate of undetectable PSA levels(5 years)
- Describe impact of treatment on quality of life(2 years)
- Estimate freedom from biochemical failure (RFS)(5 years)
- Estimate GI and sexual toxicity(2 years)
- Estimate the prevalence of grade 3 or greater GU toxicity(2 years)
研究者
Christopher Luminais, MD
Assistant Professor of Radiation Oncology
University of Virginia
研究点 (2)
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